Recall Z-1560-2026— Altruan GmbH
Class II · Ongoing
Class II FDA medical device recall by Altruan GmbH, initiated 2025-12-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.. Reason: Product not cleared by the FDA..
- Recalling firm
- Altruan GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-19
- Firm location
- Massing, N/A, Germany
Product description
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Reason for recall
Product not cleared by the FDA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.